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**PROPOSITO DE LA POSICION**
Liderar, coordinar, ejecutar e Implementar actividades relacionadas a documentar, investigar, evaluar, analizar y solucionar cualquier reclamación de nuestros clientes relacionados a nuestros productos y/o sistemas de administración de calidad.
**ROLES Y RESPONSABILIDADES**
- Asegura que las políticas, regulaciones y estándares del sistema de administración de calidad aplicables a retroalimentación/reclamaciones de clientes se cumplan.
- Genera y analiza las estadísticas necesarias para analizar la efectividad del sistema de administración de reclamaciones de cliente (Management Review/CRB).
- Coordina, supervisa, administra y ejecuta investigación efectiva de reclamaciones de cliente.
- Realiza escalaciones de quejas de cliente consideradas de alto riesgo para los pacientes o regulatorio.
- Liderar, coordinar, desarrollar y asegurar que acciones correctivas sean implementadas en nuestros productos y procesos cuando sea necesario.
- Identifica y analiza el riesgo de los modos de falla de los productos manufacturados.
- Supervisa, administra, provee dirección y retroalimentación así cómo evalúa la efectiva ejecución de actividades del personal bajo su cargo.
- Responsable de representar a la Gerencia de las áreas de aseguramiento de calidad y control de calidad de la compañía, definiendo los procedimientos adecuados y controlando los procesos, estableciendo las guías de sistemas que cumplan con las regulaciones de
- ISO 13485
- GMP
- United States (21 CFR parts 820/210/211/11)
- European Community (MDD93/42/EEC)
- Canada (Canadian Medical Device Regulations SOR/98-282)
- Brazil (ANVISA resolution RDC No.16 2013, RDC 40 2015 (Class I, II), RDC 185 2001 Class III)
- Australia (Therapeutic goods act)
- Japan (MHLW MO 169)
- Mexico COFEPRIS (NOM-241-SSA1)
**REQUERIMIENTOS DE LA POSICION**
**ESCOLARIDAD**: Profesional
**INGLES**: Nível avanzado (traducción y redacción (ingles/español))
**EXPERIENCIA**: 2 a 4 años en el área de Calidad y experiência en regulaciones para dispositivos médicos.
**CONOCIMIENTOS**: ISO 13485:2016, MDSAP
**HABILIDADES**: Comunicación efectiva, liderazgo, trabajo en equipo, ordenado, orientado a resultados, control emocional, análisis y solución de problemas, auto dirigido, tomar decisiones.
